SPARTACORERecalls & reported problems across all models

We found 4 models of SPARTACORE by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2016 and Jan 30, 2025 — classified as 12 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (14 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SPARTACORE problems

SPARTACORE models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SPARTACORE 1005203

  WIRE, GUIDE, CATHETER
  18 reports
• SPARTACORE 1005202

  WIRE, GUIDE, CATHETER
  5 reports
• SPARTACORE 1005206

  WIRE, GUIDE, CATHETER
  4 reports
• SPARTACORE 1005205

  WIRE, GUIDE, CATHETER
  1 report

Recent SPARTACORE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025Break; Stretched; Failure to Advance; Break; Stretched; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE DISTAL POPLITEAL ARTERY TIBIOPERONEAL (TP) TRUNK. A 300CM HI-TORQUE SPARTACORE 14 GUIDEWIRE (GW) WAS ADVANCED TOWARDS THE TARGET LESION WITH RESISTANCE FROM THE ANATOMY, AND MADE IT TO THE DISTAL POPLITEAL; HOWEVER, IT COULD NOT CROSS THE LESION. THE GW WAS THEN REMOVED AND IT WAS NOTED THAT THE DISTAL TIP OF THE WIRE WAS STRETCHED AND LOOKED LIKE IT HAD BEEN TORQUED AROUND. THE COILS MAY HAVE BEEN PULLED APART [SLIGHTLY UNRAVELED]. NO PART OF THE WIRE WAS SEPARATED AND THE WIRE WAS REMOVED INTACT. A COMMAND 18 WAS THEN USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21278154 ↗
• MalfunctionSep 19, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING THE PROCEDURAL PREPARATION A 190CM HI-TORQUE SPARTACORE GUIDEWIRE (GW) WAS REMOVED FROM ITS PACKAGED, WHEN IT WAS NOTED TO HAVE BLUE, FUZZY BUMP ON THE WIRE NEAR THE TIP. THE DEVICE WAS REPLACED WITH ANOTHER SPARTACORE GW AND THE PROCEDURE WAS COMPLETED THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255680 ↗
• InjuryMay 10, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  USER FACILITY MEDWATCH REPORT RECEIVED STATES "THE SURGEON WAS USING A HI-TORQUE SPARTACORE 14 GUIDE WIRE DURING A PROCEDURE, AND IT BECAME STUCK IN PATIENT. THE END OF GUIDE WIRE BROKE OFF IN PATIENT. UNABLE TO RETRIEVE A PIECE AND MD CHOSE TO LEAVE IN THE PATIENT AS THE RISKS OF REMOVAL ATTEMPT OUTWEIGHED THE BENEFIT. NO HARM TO THE PATIENT". IN ADDITION, IT WAS NOTED THAT NO INTERVENTION WAS PERFORMED AND THE TIP REMAINED FREE FLOATING IN THE PATIENT DUE TO DIFFICULTY OF THE PROCEDURE. THE PATIENT IS NOW DECEASED; HOWEVER, IT WAS NOTED THAT THE DEATH WAS NOT RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19289568 ↗
• MalfunctionJan 8, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY CALCIFIED AND TORTUOUS PROXIMAL POPLITEAL ARTERY NEAR THE TP (TIBIOPERONEAL) TRUNK. A NON-ABBOTT LASER CATHETER WAS ADVANCED OVER THE SPARTACORE GUIDE WIRE WITHOUT ANY RESISTANCE. UPON REMOVAL OF THE CATHETER, RESISTANCE WAS NOTED WITH THE GUIDE WIRE. BOTH DEVICES WERE REMOVED AS ONE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW SPARTACORE GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466714 ↗
• InjuryOct 3, 2023Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  A USER FACILITY MEDWATCH REPORT (MW5145069) WAS RECEIVED THAT STATES: DURING ANGIOGRAM, THE SPARTACARE 14 WIRE BECAME COILED AND BROKE UPON REMOVAL. ONE PIECE ABLE TO BE RETRIEVED, THE OTHER REQUIRED STENTING TO KEEP IN PLACE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17861003 ↗
• MalfunctionMar 24, 2023Difficult to Remove; Stretched; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LEFT POSTERIOR TIBIAL ARTERY. THE SPARTACORE GUIDE WIRE WAS USED WITHOUT ISSUE; HOWEVER, AT THE COMPLETION OF THE PROCEDURE, THE GUIDE WIRE WAS REMOVED WITH SOME RESISTANCE FELT AGAINST THE UNSPECIFIED DELIVERY CATHETER. UPON REMOVAL, IT WAS NOTED THAT THE SPARTACORE GUIDE WIRE COILS HAD STRETCHED; HOWEVER, THE DEVICE REMAINED IN ONE PIECE. THE ENTIRE DEVICE WAS REMOVED AND THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16614030 ↗
• MalfunctionMar 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE HI-TORQUE (HT) SPARTACORE GUIDE WIRE WAS USED SUCCESSFULLY, HOWEVER, IT WAS NOTED THAT THE GUIDE WIRE WAS EXPIRED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542035 ↗
• InjuryOct 3, 2022Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH COMPLETE OCCLUSION OF THE LOWER LEG AND SEPSIS. THE PROCEDURE WAS TO TREAT THE RESTENOSED LESION IN AN ARTERY BELOW THE KNEE WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE HI-TORQUE SPARTACORE GUIDEWIRE (GW) WAS ADVANCED WITH DIFFICULTY DUE TO THE ANATOMY. THE GW WAS USED WITH AN ATHERECTOMY SYSTEM. THEN DURING DILATATION WITH AN ARMADA BALLOON IT WAS NOTED THAT A PIECE OF THE GW REMAINED IN THE PATIENT. LATER IN THE DAY, DUE TO THE SEVERE SEPSIS, THE PATIENT'S LEG WAS AMPUTATED. PER THE PHYSICIAN, THE AMPUTATION WAS NOT RELATED TO THE GW SEPARATION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15533878 ↗
• InjuryJul 29, 2022Material Separation; No Apparent Adverse Event; Material Separation; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THERE WAS NO DIFFICULTY NOTED ADVANCING THE GUIDE WIRE TO THE TARGET LESION OR ADVANCING / WITHDRAWING ANY DEVICES OVER THE GUIDE WIRE. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY; HOWEVER, IT WAS NOTED THAT THE TIP OF THE DEVICE SEPARATED AND REMAINED IN THE PATIENT ANATOMY. THERE WAS NO ATTEMPT MADE TO REMOVE THE TIP AND THE SEPARATED SEGMENT REMAINS IN THE PATIENT ANATOMY. NO ADDITIONAL TREATMENT WAS REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15130931 ↗
• MalfunctionJul 25, 2022Break; Peeled/Delaminated; Difficult to Remove; Break; Peeled/Delaminated; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A POPLITEAL ARTERY. DURING REMOVAL OF A SPARTACORE GUIDE WIRE, RESISTANCE WAS MET WITH AN UNSPECIFIED SOURCE AND ONCE THE GW WAS REMOVED IT WAS NOTED THAT THE TIP WAS UNRAVELED (STILL IN ONE PIECE). ADDITIONALLY IT ALSO LOOKED LIKE IT SHEARED/PEELED. INTRAVASCULAR IMAGING CONFIRMED THAT NOTHING WAS LEFT IN THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099010 ↗
• MalfunctionJun 17, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT PERONEAL ARTERY WITH RIGHT GROIN ACCESS. A SPARTACORE GUIDE WIRE WAS ADVANCED AND THE 2.0X200MM ARMADA 14 BALLOON CATHETER WAS ADVANCED. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH AND THE BALLOON WAS PREPARED/FLUSHED PRIOR TO USE. THE BALLOON WAS ATTEMPTED TO BE INFLATED BUT THERE WAS A LOT OF RESISTANCE. IT TOOK A LOT OF PRESSURE TO INFLATE THE BALLOON AND IT WAS ONLY PARTIALLY INFLATED AND NOT UNIFORMLY SHAPED. THE DEVICE WAS LOSING PRESSURE BUT THERE WAS NO LEAK OF CONTRAST NOTED IN THE VESSEL AS THE BALLOON WAS INFLATING, NOR WAS THERE ANY BLOOD BACKFILLING THE INFLATION DEVICE SO IT WAS DIFFICULT TO TELL IF THERE WAS A RUPTURE. WHEN ATTEMPTING TO REMOVE THE ARMADA BALLOON, IT BECAME STUCK WITH THE SPARTACORE GUIDE WIRE IN THE SUPERFICIAL FEMORAL ARTERY AND THEY WERE PULLED OUT TOGETHER, CAUSING WIRE ACCESS TO BE LOST. THERE WAS NO ATTEMPT MADE TO MOVE THE GUIDE WIRE WHILE THE BALLOON WAS PRESSURIZED/INFLATED. THE PHYSICIAN NOTED A THREAD OF WHAT SEEMED TO BE PLASTIC MATERIAL AT THE HUB OF THE ARMADA SHEATH AND PULLED IT OUT WITHOUT INTERVENTION. IT WAS A LONG PLASTIC MATERIAL BUT ANGIOGRAPHY POST PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14735236 ↗
• MalfunctionMar 2, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION LOCATED IN A MODERATELY CALCIFIED AND DIFFICULT ANGLED RIGHT RENAL ARTERY. A HI-TORQUE (HT) SPARTACORE GUIDE WIRE WAS PLACED IN POSITION. THE HERCULINK STENT SYSTEM HAD RESISTANCE WITH THE GUIDE WIRE DURING ADVANCEMENT BUT THE PHYSICIAN GOT IT INTO POSITION. HOWEVER, THE PHYSICIAN LOST ACCESS TO THE ARTERY AND THE GUIDE WIRE POPPED FROM THE ARTERY BUT DID NOT DAMAGE THE ARTERY. THE STENT COULDN'T BE REMOVED FROM THE GUIDE WIRE SO THE STENT AND THE GUIDE WIRE WERE PULLED AS ONE UNIT. THE PROCEDURE WAS ABORTED DUE TO THE ANATOMICAL CHALLENGES. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653707 ↗
• MalfunctionFeb 26, 2022Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE 100% OCCLUDED OSTIAL SUPERIOR MESENTERIC ARTERY (SMA). THE HERCULINK ELITE STENT DELIVERY SYSTEM WAS ADVANCED OVER A LONG SPARTACORE GUIDE WIRE. NO ISSUES WERE NOTED DURING ADVANCEMENT WITH THE GUIDE WIRE, BUT DIFFICULTY WAS NOTED ADVANCING THE HERCULINK ELITE DUE TO THE PATIENT ANATOMY, SO REMOVAL OF THE DEVICE WAS INITIATED; HOWEVER, DURING REMOVAL, RESISTANCE WAS NOTED WITH THE GUIDE WIRE. THE DEVICE WAS PULLED AND THE HERCULINK ELITE STENT DELIVERY SEPARATED AT A LOCATION OUTSIDE THE PATIENT ANATOMY. AFTER REMOVING THE PROXIMAL DEVICE, THE PROXIMAL GUIDE WIRE WAS CUT TO REMOVE THE HERCULINK ELITE SEPARATED SEGMENT. THE PROCEDURE CONTINUED USING THE SAME CUT GUIDE WIRE. A SECOND HERCULINK ELITE WAS THEN IMPLANTED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13609412 ↗
• MalfunctionApr 26, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO A LESION WITH MILD CALCIFICATION BETWEEN THE POPLITEAL AND SUPERFICIAL FEMORAL ARTERY (SFA). THE SUPERA PERIPHERAL STENT SYSTEM WAS ADVANCED OVER THE SPARTA CORE GUIDE WIRE WITHOUT ISSUE AND THE STENT WAS DEPLOYED SUCCESSFULLY. DURING REMOVAL OF THE SUPERA, THE DEVICE BECAME STUCK WITH THE GUIDE WIRE AND COULD NOT BE REMOVED. THEREFORE, BOTH DEVICES HAD TO BE REMOVED AS ONE SINGLE UNIT. A NEW COMMAND GUIDE WAS ADVANCED, AND A SECOND STENT WAS DEPLOYED WITHOUT COMPLICATIONS. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11724951 ↗
• InjuryApr 12, 2021Entrapment of Device; Improper or Incorrect Procedure or Method; Entrapment of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, NON-TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE 6X80MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM WAS ADVANCED OVER A SUPRACORE GUIDEWIRE AND THE STENT WAS IMPLANTED WITHOUT ISSUE. A NON-ABBOTT GUIDING CATHETER WAS THEN USED TO REMOVE THE SUPRACORE WIRE, THEN A 0.014 HI-TORQUE SPARTACORE WIRE WAS ADVANCED THROUGH THE SAME CATHETER AND ATTEMPTED TO BE PLACED BUT THE WIRE GOT CAUGHT WITH THE IMPLANTED STENT. THE STENT PULLED BACK WITH THE WIRE AND LOOKED LIKE IT WAS GOING TO FRACTURE, BUT WHEN THE WIRE UNFURLED THE STENT SETTLED BACK INTO PLACE. A CUT DOWN WAS DONE TO REMOVE THE WIRE. THE WIRE WAS CUT BY THE PHYSICIAN TO REMOVE ANYTHING BEYOND THE STENT PROXIMALLY. THE PORTION WITHIN THE STENT REMAINS EMBEDDED IN THE VESSEL. THERE WAS NO DAMAGE TO THE STENT, AND IT REMAINS IMPLANTED IN THE TARGET LESION. A CLINICALLY SIGNIFICANT DELAY WAS REPORTED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11651202 ↗

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